1. Scope

1.1 This specification covers both virgin poly(glycolide) resin and poly(glycolide-co-lactide) resin with mole fractions greater than or equal to 70 % glycolide. This specification is not applicable to glycolide:lactide copolymers with mole fractions exceeding 30 % lactide.

1.2 Since poly(glycolide) is commonly abbreviated as PGA for poly(glycolic acid) and poly(lactide) is commonly abbreviated as PLA for poly(lactic acid), these polymers are commonly referred to as PGA and PGA:PLA resins for the hydrolytic byproducts to which they respectively degrade.

1.3 This specification addresses material characteristics of both virgin poly(glycolide) and poly(?70 % glycolide-co-lactide) resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from this material.

1.4 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated independently using appropriate test methods to ensure safety and efficacy.

1.5 This standard may suggest use of hazardous materials, operations, and equipment. This standard does not purport to address safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D1505 Test Method for Density of Plastics by the Density-Gradient Technique

D2857 Practice for Dilute Solution Viscosity of Polymers

D3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry

D4603 Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer

D5296 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography

E386 Practice for Data Presentation Relating to High-Resolution Nuclear Magnetic Resonance (NMR) Spectroscopy

E473 Terminology Relating to Thermal Analysis and Rheology

E793 Test Method for Enthalpies of Fusion and Crystallization by Differential Scanning Calorimetry

E794 Test Method for Melting And Crystallization Temperatures By Thermal Analysis

E967 Test Method for Temperature Calibration of Differential Scanning Calorimeters and Differential Thermal Analyzers

E968 Practice for Heat Flow Calibration of Differential Scanning Calorimeters

E1142 Terminology Relating to Thermophysical Properties

E1252 Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis

E1356 Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry

E1994 Practice for Use of Process Oriented AOQL and LTPD Sampling Plans

F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

F1925 Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

F2579 Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

Keywords

poly(glycolic acid); poly(glycolide); PGA; poly(glycolide:lactide); poly(glycolide-co-lactide); PLA; PGA:PLA; PLA:PGA; PLGA; polyglycolic:lactic acid; poly(glycolide-co-lactide); poly(glycolide:lactide); poly(lactic acid); polylactic:glycolic acid; poly(lactide); poly(lactide-co-glycolide); poly(lactide:glycolide); polylactide; Poly(glycolic acid)(PGA); Poly(glycolide); Poly(glycolide-co-lactide); Polymers--specifications; Surgical implants--specifications ;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 83.080.10 (Thermosetting materials)

DOI: 10.1520/F2313-03

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